BACKGROUND
[0001] Monitoring of the location of neural elements can reduce the likelihood of neural
damage while accessing anatomical structures near the nerve. Systems exist which provide
for delivery of an electrical current for detection of neural element proximity to
a carrier of the current by visibly noting a patient's limb motor reaction when the
neural element is stimulated by electrical current.
[0002] Surgical needle assemblies can be employed for access, treatment and/or delivery
of treatment to locations within a patient's body. The needle assembly is inserted
for penetration of soft and hard tissues of the patient during the initial steps of
the treatment protocol without determining the proximity of neural elements to the
needle assembly during and after such placement of the needle assembly. Subsequent
treatments and procedures that are carried out based on the initial needle insertion
position may impinge or interfere with the neural elements, requiring relocation of
the treatment location or pathway.
[0003] US-A-2004/122482 (Tung James et al.) describes a method and apparatus for proximity detection and confirmation of treatment
of a target nerve such as the facet nerve. The apparatus includes a probe that can
deliver electrical current for stimulation of the facet nerve, and physiological sensors
for transduction of multifidus muscle activity. A generator produces electrical current
at physiological stimulation frequencies, and physiological sensor signals of muscle
activity are displayed, analyzed and recorded with the use of a measuring device.
A method using stimulation-induced multifidus activity to localize and confirm treatment
of the facet nerve is also described.
SUMMARY
[0004] The present invention is defined in the appended claims and includes a surgical tool
useable by a surgeon to penetrate soft and hard tissue of the patient with a needle
assembly. The needle assembly can be electrically coupled to a nerve monitoring system
to allow the monitoring and detection of neural elements as the needle assembly is
advanced into the patient through skin and tissue. The distal tip of the needle assembly
carries the electrical signal, and the outer surface of the needle assembly is insulated
to prevent shunting of the signal to tissue or instruments proximal of the distal
tip. Corrective action to avoid impingement or to provide sufficient spacing from
neural elements can taken during needle assembly placement, reducing the likelihood
that corrective actions will need to be taken later in the surgical procedure to avoid
or provide sufficient clearance with neural elements.
[0005] In one example not forming part of the present invention, the needle assembly is
removably engageable to a handle assembly that facilitates manipulation and control
of the needle assembly as it is advanced into the patient. In one embodiment, the
handle assembly is configured to allow gripping thereof by the hand of the surgeon
while maintaining the electrical lead coupling the needle assembly to the nerve monitoring
system out of the way of the surgeon.
[0006] In one procedure not forming part of the present invention, the surgical tool is
used in minimally invasive spinal surgical procedures. The needle assembly is percutaneously
advanced into the patient and engaged to the pedicle of a vertebra. During such engagement,
the proximity of neural elements to the distal tip is monitored to allow for corrective
action to be taken to avoid or provide sufficient spacing of the needle assembly from
neural elements during this initial access phase of the procedure. When the needle
is engaged to the pedicle at the desired location, the handle assembly is removed
from the needle assembly. The needle assembly includes a cannula housing a stylet,
and the stylet is removed so that the cannula remains engaged to the pedicle. A guidewire
can be positioned through the lumen of the cannula, and the cannula withdrawn. The
guidewire can then guide other instruments, implants or other surgical devices or
instruments to the pedicle. Other procedures are contemplated at locations along the
spinal column other than the pedicles, and at other locations within the body of the
patient other than the spinal column.
BRIEF DESCRIPTION OF THE FIGURES
[0007]
Fig. 1 is a view of the surgical field with an assembled perspective view of a surgical
tool and nerve and monitoring system.
Fig. 2 is an elevation view in partial section of the surgical tool including a needle
assembly coupled to a handle assembly.
Fig. 3A is a section view along line 3A-3A of Fig. 2.
Fig. 3B is a distal end view of the handle assembly of Fig. 2.
Fig. 4 is an elevation view of a stylet comprising a portion of the needle assembly
of Fig. 1.
Fig. 5A is an elevation view of a cannula comprising a portion of the needle assembly
of Fig. 1.
FIG. 5B is a section view along line 5B-5B of Fig. 5A.
FIG. 6 is an elevation view of a lead comprising a portion of the surgical tool of
Fig. 1.
FIG. 7 is an elevation view of a housing comprising a portion of the handle assembly.
FIG. 8 is a section view through line 8-8 of Fig. 7.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0008] While this device is susceptible of embodiment in many different forms, there is
shown in the drawings, and will herein be described in detail, several specific embodiments,
with the understanding that the present disclosure can be considered as an exemplification
and is not intended to be limited to the embodiments illustrated.
[0009] The present system relates to surgical tools used in accessing locations within the
body of the patient while monitoring the proximity of neural elements to the tool.
The surgical tool includes a needle assembly electrically engageable to a nerve monitoring
system, where the needle assembly is operable to carry an electrical signal at its
distal tip and allow the surgeon to monitor the proximity of neural elements with
the nerve monitoring system as the needle is advanced to the target location in the
patient. The proximity of the needle assembly to the neural elements can be controlled
to reduce the potential neural element impact of needle insertion and subsequent procedures
carried out based on the needle insertion location. The target location may include
bony structures, an organ, a canal or space, a tumor or other defect, or any anatomical
location or structure within a patient. The needle assembly includes a structure that
facilitates operative positioning and control by the surgeon during the procedure.
Once the needle has been positioned at the target location, subsequent procedures
can be carried out. Such subsequent procedures can include therapy, implants, substances,
or the like provided by, through or upon the needle assembly. Subsequent procedures
may also include using the needle assembly as a platform or guide for subsequent placement
of instruments, implants and other devices and therapeutic materials.
[0010] The needle assembly includes a distal needle structure positionable within the patient
and operable to carry an electrical signal, a handle assembly, and an electrical lead.
In one example, the needle structure is removably engageable to the handle assembly,
although embodiments where the needle assembly is integral with the handle assembly
are also contemplated. The needle assembly is operable to deliver an electrical signal,
such as a current, to a location in the patient's body to monitor proximity of the
neural elements to the inserted end of the needle structure. The lead can extend from
the handle assembly to an electrical signal source. Another lead can be used to ground
the circuit. The needle assembly, when assembled with the handle assembly, can be
completely insulated, except for the distal insertion end, to prevent shunting of
the electrical signal to tissue or instruments located proximally of the insertion
end.
[0011] Referring to Figs. 1 and 2, there is provided view of a surgical field 24 that includes
a portion of the posterior spinal column shown in hidden lines beneath the skin and
tissue of a patient and surgical tool 20. Surgical field 24 includes spinal column
segment 25 having a number of vertebrae therealong, it being understood that surgical
tool 20 can have application in any region of the spine and in any approach to the
spine. It is also understood that surgical tool 20 has application in procedures other
than spinal surgical procedures.
[0012] Surgical tool 20 includes a needle assembly 30 and a handle assembly 80. Needle assembly
30 is received in a receptacle 86 extending axially into handle assembly 80. Needle
assembly 30 can be electrically coupled to a nerve monitoring system 22 via lead 100
when positioned in receptacle 86. Lead 100 extends into handle assembly 80 via a lateral
bore 88, where it is electrically coupled to needle assembly 30. A second reference
27 coupled to a patient (not shown) can be provided as a ground. In one procedure,
the needle assembly 30 is positionable through the skin and soft and hard tissues
of the patient to a surgically appropriate target locations such as, for example,
the pedicle of a vertebra of spinal column segment 25. Subsequent procedures and instruments
for accessing the spinal column can then be employed using the needle assembly and
target location obtained thereby as a minimally invasive platform for treatment and/or
placement of devices and implants to treat conditions associated with the spinal column.
[0013] Needle assembly 30 includes a cannula 40 and stylet 60 removably received in a central
lumen of cannula 40 along a longitudinal axis 38. Stylet 60 may include any suitable
distal tip configuration, such as a trocar tip configuration as shown or a beveled
tip configuration. Other embodiments contemplate a needle assembly that includes a
single needle element. The needle element can be solid or cannulated. In the illustrated
embodiment, handle assembly 80 is removably positioned about the proximal ends of
cannula 40 and stylet 60 and engaged thereto to facilitate handling and positioning
of needle assembly 30 through skin and tissue to the target location in the patient's
body. An outer sheath 32 may also be provided for positioning about cannula 40 and/or
stylet 60. Sheath 32 may be provided with a length extending to a distal end thereof
(not shown) that extends distally beyond the distal ends of cannula 40 and/or stylet
60. Sheath 32 can facilitate pre-operative handling of needle assembly 30 to prevent,
for example, accidental punctures, cutting and contamination of needle assembly 30.
[0014] Stylet 60 is shown in isolation in Fig. 4. Stylet 60 includes a pointed tip 62 adjacent
its distal end and an elongate shaft 64 extending proximally from tip 62. A hub 66
is provided at the proximal end of shaft 64. Hub 66 includes an enlarged body 70 extending
radially about shaft 64, and a proximal extension 68 extending proximally from body
70.
[0015] Cannula 40 is shown-in Figs. 5A and 5B. Cannula 40 includes a central lumen 41 extending
therealong and opening at a distal end 42 and a proximal end 53. The outer surface
area of cannula 40 may be covered or coated with a non-conductive or insulative material
or member to prevent shunting of electricity from cannula 40 to adjacent tissue or
instruments. A distal cannula portion 44 extends proximally from distal end 42 to
a transition portion 48. Transition portion 48 extends to a proximal cannula portion
46. Proximal cannula portion 46 may include a greater outside diameter than distal
cannula portion 44 to provide sufficient rigidity to cannula 40 while minimizing the
size of the leading end of cannula 40. Distal end 42 may also be beveled to facilitate
penetration and passage of cannula 40 through skin and tissue to the target location
in the patient. Other examples contemplate a single diameter cannula, or a cannula
with more than two diameters.
[0016] The proximal end of cannula 40 includes a connection member 50. Connection member
50 may be comprised of a non-conductive material, or of a conductive material having
an insulated coating. Connection member 50 includes a proximal end fitting 52 configured
to facilitate attachment of various devices to cannula 40. In one embodiment, fitting
52 provides a luer-type connection. Other embodiments contemplate other connection
arrangements that are provided by fitting 52. Connection member 50 may further includes
a distal sleeve portions 54 extending about proximal cannula portion 46. Distal sleeve
portion 54 overlaps the insulated surface area of cannula portion 46 to ensure the
cannula 40 is entirely insulated adjacent its proximal end.
[0017] Connection member 50 also includes a gripping portion 56 with opposite, laterally
extending wings and concave surface depressions that allow the user to grip cannula
40 to facilitate handling when handle assembly 80 is removed. Connection member 50
also includes a proximal sleeve portion 57 extending proximally from gripping portion
56. Notches 58 are provided in opposite sides of sleeve portion 57, and as discussed
further below, are engageable by a locking element to secure cannula 40 to handle
assembly 80. Stylet 60 is positionable in cannula 40 so that distal tip 62 projects
distally of distal end 42 when hub 66 is positioned against the proximal end of connection
member 50.
[0018] Referring to Fig. 6, there is shown lead 100 that extends from handle assembly 80
and is electrically engageable to stylet 60 when stylet 60 is engaged in handle assembly
80. Lead 100 includes a flexible cable portion 102 extending between a connector 106
at one end and a contact 104 at the opposite end. Connector 106 and cable portion
102 can include an outer surface layer that is plastic to facilitate cleaning and
protect the conductive wiring, leads and other electrical transmission structures
therein. Connector 106 can be configured for electrical engagement with a lead from
a nerve monitoring system or the like such as the NIM-Spine™ System marketed by Medtronic,
Inc. or any other suitable nerve monitoring system.
[0019] Contact 104 is housed within handle assembly 80, and is electrically engageable to
proximal extension 68 of stylet 60 when hub 60 is positioned in handle assembly 80.
In the illustrated embodiment, housing 108 is positioned in the laterally oriented
bore 88 of handle 80 to secure lead 100 to handle assembly 80. Housing 108 includes
a body 110 and a longitudinal trough 112 extending therealong and opening along a
side of housing 108. Body 110 includes axial protrusions 114 and lateral protrusions
116 projecting into trough 112 that engage cable 102 and maintain it in position in
trough 112. In particular, the opposing lateral protrusions provide restraint of cable
102 within body 110, and the axial protrusions push and facilitate frictional engagement
of cable 102 against the inner surface defining bore 88. Body 110 can be engaged in
bore 88 via any one or combination of a friction fit, fasteners, adhesives or welding
or fusing of body 110 to handle 80.
[0020] With body 110 securely positioned in bore 88, contact 104 projects into a proximal
portion 94 of receptacle 86. The proximal extension 68 of hub 60 is comprised of an
electrically conductive material that contacts contact 104 in proximal portion 94
and electrically couples stylet 60 and cannula 40 to the electrical signal source.
[0021] Cannula 40 and stylet 60 may be made of stainless surgical steel or other suitable
conductive material of sufficient strength to penetrate tissue of the patient to the
target location. Cannula 40 and stylet 60 can be constructed from a single piece of
suitable conductive material or could be constructed from more than one piece of suitable
conductive material. Cannula 40 is provided with an insulated surface area between
its distal and proximal ends that can be achieved through the use of a coating, e.g.
polyamide coating or through other means, such as an overlaying sleeve of foam or
other material. The insulated surface area ensures the electrical signal is directed
to the target area adjacent the distal ends of stylet 60 and cannula 40 and is not
shunted to surrounding, unintended, tissue or surgical instruments.
[0022] Handle assembly 80 is shown in Figs. 2 and 3A-3B. Handle assembly 80 comprises a
handle body 82 with an electrically insulated surface area 90 and an electrically
conductive area 95 internal to handle body 82. Access to electrically conductive area
95 is provided via a distally opening receptacle 86 in a distally extending neck portion
84 of handle body 82. Neck portion 84 includes a channel 96 that receives a locking
element 76. A lateral bore 88 extends transversely to and opens at a lateral surface
92 of handle body 82. Lead 100 is positioned in bore 88.
[0023] Handle body 82 of handle assembly 80 includes a proximal gripping portion formed
to include a major dimension 83 and a minor dimension 85. The major and minor dimensions
83, 85 are measured orthogonally to one another and orthogonally to an extension of
longitudinal axis 38 through handle body 82. In one embodiment, the major dimension
is at least 50% greater than the minor dimension. The provision of handle body 82
with a gripping portion having such major and minor dimensions in this manner accommodates
the hand of the surgeon or other attendant, and facilitates manipulation and control
of needle assembly 30 with handle assembly 80. The proximal end of body 82 includes
continuously curved outer surfaces at its interface with the user's hand. This enables
a user to have a secure and comfortable grasp on the handle assembly 80. Furthermore,
bore 88 extends along the major dimension to position lead 100 away from the gripping
surfaces of body 82. Lead 100 exits one of the lateral surfaces 92 to prevent lead
100 from interfering with gripping and control of needle assembly 30.
[0024] In another embodiment, lead 100 is engageable with an outlet or receptacle provided
adjacent lateral surface 92. The outlet or receptacle is electrically coupled to needle
assembly 30 in handle assembly 80.
[0025] Channel 96 in neck portion 84 opens into axially extending receptacle 86 formed in
handle body 82. Receptacle 86 can include a distal portion that has the same cross-sectional
size and shape as the proximal end hub 66 provided on stylet 60. In addition, the
proximal end connection member 50 of cannula 40 includes a proximal sleeve portion
57 having the same size and shape as receptacle 86. The form fitting engagement between
receptacle 86 and fitting 50 and hub 66 prevents rotation and provides a secure connection
that eliminates movement between needle assembly 30 and handle assembly 80. In the
present embodiment, receptacle 86 has an oblong shape that is asymmetric. As a result,
receptacle 86 will receive the proximal end portions of stylet 60 and cannula 40 when
in proper alignment with the shape of receptacle 86.
[0026] When assembled, proximal sleeve portion 57 of connection member 50 of cannula 40
occupies receptacle 86 adjacent channel 96, and notches 58 of sleeve portion 57 are
aligned relative to channel 96. Cannula 40 is secured in receptacle 86 by locking
element 76 in channel 96. In one embodiment, stylet 60 is press fit into receptacle
86 for engagement with handle assembly 80 so that proximal extension 68 of stylet
60 extends into a smaller proximal portion 94 of receptacle 86 and maintains a constant
electrical connection with contact 104 of lead 100, thereby electrically coupling
lead 100 to needle assembly 30.
[0027] In another example, stylet 60 is removable from handle assembly 80 and also removable
from cannula 40. In this example, the electrical connection between lead 100 and stylet
60 can be maintained by any conventional means known to a person skilled in the art,
such as a spring made of a conductive material. Such a spring could be mounted in
bore 88 or receptacle 86, such that it makes contact with a conductive area of stylet
60 or cannula 40 when attached to handle assembly 80. The releasable connection also
does not interfere with removal of handle assembly 80 from needle assembly 30 when
it is desired to withdraw stylet 60 from cannula 40.
[0028] In the illustrated embodiment, channel 96 comprises a shallow channel extending circumferentially
about neck portion 84, and extends approximately three-quarters of the way around
neck portion 84. Channel 96 includes through-holes 97, 99, which are located opposite
from one another and open into side portions of receptacle 86. Channel 96 begins at
first through-hole 97, and extends counterclockwise approximately one-quarter revolution
past second through-hole 99 where it terminates.
[0029] Locking element 76 can be in the form of a substantially flat, semicircular member
having an aperture diameter slightly larger than the inner diameter of channel 96.
Locking element 76 an outer gripping surface 78, which facilitates rotation of locking
element 76 by the user. Locking element 76 is adapted to fit within channel 96 and
has an outer circumference extending slightly less than three-quarters around neck
portion 84.
[0030] Locking element 76 can be manipulated and rotated within channel 96 about a small
angular displacement on the order of one-eighth of one rotation. This effectively
allows for locking element 76 to be toggled between two positions, which correspond
to the locked and unlocked configurations relative to handle assembly 80. When locking
element 76 is rotated counterclockwise, no portions of locking element 76 protrude
through through-holes 97 and 99, as shown in Fig. 3A, and locking element 76 does
not obstruct receptacle 86. In this configuration, a groove 72 of locking element
76 is aligned with second through-hole 99, and on the other side of channel 96, the
end 74 of locking element 76 is located slightly counterclockwise of second through-hole
97. This position corresponds to the unlocked orientation which allows removal and
insertion of cannula 40 and hub 60 relative to handle assembly 80. Alternatively,
when locking element 76 is rotated clockwise as far as possible, groove 72 is no longer
aligned with through-hole 99, thereby causing a portion of locking element 76 to protrude
through through-hole 99 and obstruct one side portion of passage 86. Additionally,
the end 74 of locking element 76 now protrudes through the other through-hole 97,
obstructing the other side portion of passage 86. This position of locking element
76 corresponds to the locked orientation which engages cannula 40 in handle assembly
80.
[0031] In order to join handle assembly 80 to cannula 40, connection member 50 is inserted
through the distal opening of receptacle 86 of handle assembly 80 when locking element
76 is in the unlocked orientation. If locking element 76 is in the locked orientation,
then side portions of receptacle 86 will be obstructed by locking element 76 at through-holes
97, 99, thereby preventing full insertion of cannula 40 into handle assembly 80. When
proximal sleeve portion 57 is fully inserted into passage 86, enlarged gripping portion
56 will abut the distal end of neck portion 84 of handle assembly 80, and notches
58 in sleeve portion 57 will be aligned with through-holes 97, 99.
[0032] Proximal extension 68 of stylet 60 is electrically engaged with contact 104 of lead
100 in handle assembly 80. Once the proximal portion of cannula 40 has been fully
inserted into receptacle 86, the user may then lock handle assembly 80 to needle assembly
30 by rotating locking element 76 clockwise relative to its Fig. 3 orientation. As
locking element 76 is rotated from its unlocked position to its locked position, needle
assembly 30 is fixed in place within receptacle 86. Portions of locking element 76
protrude through through-holes 97, 99 into notches 58 to secure at least cannula 40
of needle assembly 30 in position relative to handle assembly 80. The user of needle
assembly 30 can use a large amount of force, if necessary, to manipulate and penetrate
needle assembly 30 through tissue and/or bone, without undesired movement of needle
assembly 30 relative to handle assembly 80.
1. A surgical tool (20) for penetrating tissue and monitoring the proximity of neural
elements, comprising:
a needle assembly (30) extending along a longitudinal axis (38), said needle assembly
(30) comprising:
a stylet (60) including an electrically conductive portion near a pointed distal end,
a shaft extending proximally from said distal end providing a conductive path to a
proximal extension (68) of said stylet (60);
a cannula (40) including an insulated outer surface area and a length wherein said
pointed distal end of said stylet (60) projects distally from said insulated surface
area when said stylet (60) is positioned in said cannula (40);
a handle assembly (80) attachable near said proximal end of said needle assembly (30)
comprising:
an electrically insulated outer surface area (90);
an electrically conductive area (95) internal to said electrically insulated outer
surface area (90) and engageable with said proximal extension (68) of said stylet
(60); and
an electrical lead (100);
characterised in that said handle assembly (80) includes a gripping portion having a major dimension (83)
at least 50% greater than a minor dimension (85), said major and minor dimensions
(83, 85) being measured orthogonally to said longitudinal axis (38) and to one another;
and
said electrical lead (100) extends from said electrically conductive area (95) through
said handle assembly (80) along said major dimension (83);
wherein said handle assembly (80) includes a handle body (82) having a bore (88) extending
along said major dimension (83) from a lateral outer surface (92) of said handle body
(82) to a receptacle (86) aligned along said longitudinal axis (38) of said needle
assembly (30) when said handle assembly (80) is engaged thereto, said lead (100) extending
through said bore (88); and
wherein the surgical tool (20) further comprises a body (110) positionable in said
bore (88), said body (110) defining a trough (112) for receiving a cable portion (102)
of said lead (100) and securing said cable portion (102) in said handle assembly (80),
where the body (110) includes axial protrusions (114) and lateral protrusions (116)
projecting into the trough for engaging the cable (102) and maintaining it in position
in the trough (112).
2. The surgical tool of claim 1, wherein said cannula (40) includes a distal end positioned
proximally of said distal pointed end of said stylet (60) when said stylet (60) is
positioned in said cannula (40).
3. The surgical tool of claim 2, wherein said cannula (40) includes a connection member
(50) on a proximal end thereof and said stylet (60) includes a hub (66) about a proximal
end of said stylet (60) positonable in abutting engagement with a proximal end of
said connection member (50) of said cannula (40).
4. The surgical tool of claim 3, wherein said hub (66) includes a body (70) extending
about said shaft and said proximal extension (68) of said stylet (60) extends proximally
from said body (70).
5. The surgical tool of claim 3, wherein said connection member (50) on said cannula
(40) includes a gripping portion (56) projecting outwardly from said cannula (40),
a first sleeve portion (54) extending about said cannula (40) distally of said gripping
portion (56), and a second sleeve portion (57) about said cannula (40) proximally
of said gripping portion (56).
6. The surgical tool of claim 5, wherein said second sleeve portion (57) includes a pair
of notches (58) for receiving a locking element (76) to couple said needle assembly
(30) to said handle assembly (80) with said hub (66) and said connection member (50)
at least partially received in said handle assembly (80).
7. The surgical tool of claim 1, wherein said proximal extension (68) of said stylet
(60) fits inside a receptacle within said handle assembly (80), said receptacle including
an electrical contact for engaging said proximal extension (68) and electrically coupling
said needle assembly (30) with said lead (100).
8. The surgical tool of claim 1, wherein said cannula (40) includes a distal end beveled
to facilitate movement of said cannula (40) through tissue of the patient.
9. The surgical tool of claim 1, wherein said cannula (40) includes a lumen (41) having
a generally constant size between distal and proximal ends of said cannula (40).
10. The surgical tool of claim 1, wherein said lead (100) extends along said major dimension
(83) of said handle assembly (80) and exits said handle assembly (80) at a location
distally of said curved surfaces to avoid interfering with the user's hand positioned
about said gripping portion.
1. Chirurgisches Werkzeug (20) zum Penetrieren von Gewebe und Überwachen der Proximität
von neuralen Elementen, das Folgendes beinhaltet:
eine Nadelbaugruppe (30), die sich entlang einer Längsachse (38) erstreckt, wobei
die Nadelbaugruppe (30) Folgendes beinhaltet:
ein Stilett (60), das einen elektrisch leitfähigen Abschnitt nahe einem zugespitzten
distalen Ende, einen Schaft, der sich proximal aus dem distalen Ende erstreckt, wodurch
ein leitfähiger Weg an eine proximale Verlängerung (68) des Stiletts (60) bereitgestellt
wird, umfasst;
eine Kanüle (40), die einen isolierten äußeren Oberflächenbereich und eine Länge,
worin das zugespitzte distale Ende des Stiletts (60) distal aus dem isolierten Oberflächenbereich
vorspringt, wenn das Stilett (60) in der Kanüle (40) positioniert ist, umfasst;
eine Griffbaugruppe (80), die nahe dem proximalen Ende der Nadelbaugruppe (30) anbrachbar
ist, die Folgendes beinhaltet:
einen elektrisch isolierten äußeren Oberflächenbereich (90);
einen elektrisch leitfähigen Bereich (95), der intern zum elektrisch isolierten äußeren
Oberflächenbereich (90) liegt und mit der proximalen Verlängerung (68) des Stiletts
(60) eingreifbar ist; und
eine elektrische Leitung (100);
dadurch gekennzeichnet, dass die Griffbaugruppe (80) einen Greifabschnitt umfasst, der eine große Abmessung (83)
aufweist, die mindestens 50 % größer als eine kleine Abmessung (85) ist, wobei die
große und kleine Abmessung (83, 85) orthogonal zur Längsachse (38) und zueinander
gemessen werden; und
sich die elektrische Leitung (100) aus dem elektrisch leitfähigen Bereich (95) durch
die Griffbaugruppe (80) entlang der großen Abmessung (83) erstreckt;
wobei die Griffbaugruppe (80) einen Griffkörper (82) umfasst, der eine Bohrung (88)
aufweist, die sich entlang der großen Abmessung (83) aus einer lateralen äußeren Oberfläche
(92) des Griffkörpers (82) zu einem Behältnis (86) erstreckt, das entlang der Längsachse
(38) der Nadelbaugruppe (30) ausgerichtet ist, wenn die Griffbaugruppe (80) damit
eingegriffen ist, wobei sich die Leitung (100) durch die Bohrung (88) erstreckt; und
wobei das chirurgische Werkzeug (20) ferner einen Körper (110) beinhaltet, der in
der Bohrung (88) positionierbar ist, wobei der Körper (110) eine Tiefe (112) zum Aufnehmen
eines Kabelabschnitts (102) des Leiters (100) und Sichern des Kabelabschnitts (102)
in der Griffbaugruppe (80) definiert, wobei der Körper (110) axiale Vorsprünge (114)
und laterale Vorsprünge (116) umfasst, die in die Tiefe vorspringen, um das Kabel
(102) in Eingriff zu bringen und es in der Tiefe (112) in Position zu halten.
2. Chirurgisches Werkzeug gemäß Anspruch 1, wobei die Kanüle (40) ein distales Ende umfasst,
das proximal zum distalen zugespitzten Ende des Stiletts (60) positioniert ist, wenn
das Stilett (60) in der Kanüle (40) positioniert ist.
3. Chirurgisches Werkzeug gemäß Anspruch 2, wobei die Kanüle (40) ein Verbindungsglied
(50) an einem proximalen Ende davon umfasst und das Stilett (60) eine Nabe (66) um
ein proximales Ende des Stiletts (60) umfasst, die in Stoßeingriff mit einem proximalen
Ende des Verbindungsglieds (50) der Kanüle (40) positionierbar ist.
4. Chirurgisches Werkzeug gemäß Anspruch 3, wobei die Nabe (66) einen Körper (70) umfasst,
der sich um den Schaft erstreckt, und wobei sich die proximale Verlängerung (68) des
Stiletts (60) proximal aus dem Körper (70) erstreckt.
5. Chirurgisches Werkzeug gemäß Anspruch 3, wobei das Verbindungsglied (50) an der Kanüle
(40) einen Greifabschnitt (56), der von der Kanüle (40) nach außen vorspringt, einen
ersten Buchsenabschnitt (54), der sich um die Kanüle (40) distal vom Greifabschnitt
(56) erstreckt, und einen zweiten Buchsenabschnitt (57) der sich um die Kanüle (40)
proximal vom Greifabschnitt (56) erstreckt, umfasst.
6. Chirurgisches Werkzeug gemäß Anspruch 5, wobei der zweite Buchsenabschnitt (57) ein
Paar Kerben (58) zum Aufnehmen eines Verriegelungselements (76) umfasst, um die Nadelbaugruppe
(30) an der Griffbaugruppe (80) zu koppeln, mit der Nabe (66) und dem Verbindungsglied
(50) mindestens teilweise in der Griffbaugruppe (80) aufgenommen.
7. Chirurgisches Werkzeug gemäß Anspruch 1, wobei die proximale Verlängerung (68) des
Stiletts (60) in ein Behältnis innerhalb der Griffbaugruppe (80) passt, wobei das
Behältnis einen elektrischen Kontakt umfasst, um die proximale Verlängerung in Eingriff
zu bringen (68) und die Nadelbaugruppe (30) mit der Leitung (100) elektrisch zu koppeln.
8. Chirurgisches Werkzeug gemäß Anspruch 1, wobei die Kanüle (40) ein distales Ende umfasst,
das angeschrägt ist, um die Bewegung der Kanüle (40) durch das Gewebe des Patienten
zu erleichtern.
9. Chirurgisches Werkzeug gemäß Anspruch 1, wobei die Kanüle (40) ein Lumen (41) umfasst,
das eine im Allgemeinen konstante Größe zwischen distalem und proximalem Ende der
Kanüle (40) aufweist.
10. Chirurgisches Werkzeug gemäß Anspruch 1, wobei sich die Leitung (100) entlang der
großen Abmessung (83) der Griffbaugruppe (80) erstreckt und die Griffbaugruppe (80)
an einer Stelle distal von den gekrümmten Oberflächen verlässt, um Interferieren mit
der Hand des Benutzers zu vermeiden, die um den Greifabschnitt positioniert ist.
1. Instrument chirurgical (20) pour pénétrer un tissu et contrôler la proximité d'éléments
neuraux, comprenant :
un ensemble aiguille (30) disposé le long d'un axe longitudinal (38), ledit ensemble
aiguille (30) comprenant :
un stylet (60) comprenant une partie conductrice de l'électricité près d'une extrémité
distale pointue, un arbre s'étendant en position proximale de ladite extrémité distale
fournissant un chemin conducteur à une extension proximale (68) dudit stylet (60)
;
une canule (40) comprenant une superficie extérieure isolée et une longueur dans laquelle
ladite extrémité distale pointue dudit stylet (60) dépasse en position distale de
ladite superficie isolée lorsque ledit stylet (60) est positionné dans ladite canule
(40) ;
un ensemble poignée (80) pouvant être fixé près de ladite extrémité proximale dudit
ensemble aiguille (30) comprenant :
une superficie extérieure isolée électriquement (90) ;
une surface conductrice de l'électricité (95) intérieure à ladite superficie extérieure
isolée électriquement (90) et pouvant s'engager avec ladite extension proximale (68)
dudit stylet (60) ; et
un fil électrique (100) ;
caractérisé en ce que ledit ensemble poignée (80) comprend une partie de préhension ayant une grande dimension
(83) au moins 50% plus grande qu'une petite dimension (85), lesdites grande et petite
dimensions (83, 85) étant mesurées perpendiculairement audit axe longitudinal (38)
et l'une à l'autre ; et
ledit fil électrique (100) dépasse de ladite surface conductrice de l'électricité
(95) à travers ledit ensemble poignée (80) le long de ladite grande dimension (83)
;
dans lequel ledit ensemble poignée (80) comprend un corps de poignée (82) ayant un
alésage (88) s'étendant le long de la grande dimension (83) à partir d'une surface
extérieure latérale (92) dudit corps de poignée (82) jusqu'à un logement (86) aligné
le long dudit axe longitudinal (38) dudit ensemble aiguille (30) lorsque ledit ensemble
poignée (80) y est engagé, ledit fil (100) s'étendant à travers ledit alésage (88);
et
ledit instrument chirurgical (20) comprenant en outre un corps (110) pouvant être
positionné dans ledit alésage (88), ledit corps (110) définissant un creux (112) pour
recevoir une partie câble (102) dudit fil (100) et fixant ladite partie câble (102)
dans ledit ensemble poignée (80), où le corps (110) comprend des saillies axiales
(114) et des saillies latérales (116) dépassant dans le creux pour s'engager avec
le câble (102) et le maintenir en position dans le creux (112).
2. Instrument chirurgical selon la revendication 1, dans lequel ladite canule (40) comprend
une extrémité distale positionnée à proximité de ladite extrémité pointue distale
dudit stylet (60) lorsque ledit stylet (60) est positionné dans ladite canule (40).
3. Instrument chirurgical selon la revendication 2, dans lequel ladite canule (40) comprend
un élément de raccordement (50) sur son extrémité proximale et ledit stylet (60) comprend
un moyeu (66) autour d'une extrémité proximale dudit stylet (60) positionnable en
engagement bout à bout avec une extrémité proximale dudit élément de raccordement
(50) de ladite canule (40).
4. Instrument chirurgical selon la revendication 3, dans lequel ledit moyeu (66) comprend
un corps (70) disposé autour dudit arbre et ladite extension proximale (68) dudit
stylet (60) est disposée en position proximale par rapport audit corps (70).
5. Instrument chirurgical selon la revendication 3, dans lequel l'élément de raccordement
(50) sur ladite canule (40) comprend une partie de préhension (56) dépassant vers
l'extérieur de ladite canule (40), une première partie formant manchon (54) disposée
autour de ladite canule (40) en position distale par rapport à ladite partie de préhension
(56), et une deuxième partie formant manchon (57) autour de ladite canule (40) en
position proximale par rapport à ladite partie de préhension (56).
6. Instrument chirurgical selon la revendication 5, dans lequel ladite partie formant
manchon (57) comprend une paire d'encoches (58) pour recevoir un élément de blocage
(76) pour coupler ledit ensemble aiguille (30) audit ensemble poignée (80), ledit
moyeu (66) et ledit élément de raccordement (50) étant au moins partiellement reçus
dans ledit ensemble poignée (80).
7. Instrument chirurgical selon la revendication 1, dans lequel ladite extension proximale
(68) dudit stylet (60) s'adapte à l'intérieur d'un logement dans ledit ensemble poignée
(80), ledit logement comprenant un contact électrique assurant l'engagement avec ladite
extension proximale (68) et le couplage électrique dudit ensemble aiguille (30) avec
ledit fil (100).
8. Instrument chirurgical selon la revendication 1, dans lequel ladite canule (40) comprend
une extrémité distale biseautée pour faciliter le déplacement de ladite canule (40)
à travers le tissu du patient.
9. Instrument chirurgical selon la revendication 1, dans lequel ladite canule (40) comprend
une lumière (41) ayant une taille généralement constante entre les extrémités distale
et proximale de ladite canule (40).
10. Instrument chirurgical selon la revendication 1, dans lequel ledit fil (100) s'étend
le long de ladite grande dimension (83) dudit ensemble poignée (80) et sort dudit
ensemble manche (80) à un emplacement distal desdites surfaces courbes pour éviter
une interférence avec la main de l'utilisateur positionnée autour de la partie de
préhension.